WHO Updates
The latest guidances, approvals, and safety alerts from WHO, curated by automated regulatory intelligence.
Solicits RFQs from interested European Notified Bodies to expand WHO’s technical assessment capacity for the prequalification assessment of medical devices and…
Publishes a new AMD (Assessment of Medicines/Assessment Methodologies) newsletter issue (Q3 2026, Issue 54) that consolidates recent regulatory updates and…
Launches WHO Prequalification of Medical Devices via an informational webinar, indicating an institutionalized pathway for manufacturers to seek WHO…
Expands access to WHO Emergency Use Listing diagnostics by listing the Xpert® Hemorrhagic Fever Panel under the WHO Emergency Use List for Bundibugyo virus…
Expands WHO in vitro diagnostics (IVD) prequalification scope effective 1 September 2026 to include Interferon-Gamma Release Assays (IGRAs) for tuberculosis…
Expands WHO medical device prequalification to include additional life-saving device categories, specifically contraceptives and innovative tuberculosis (TB)…
Expands WHO IVD prequalification scope to include Interferon-Gamma Release Assays (IGRAs) and targeted Next-Generation Sequencing (tNGS) assays for…
WHO prequalification has been granted for bedaquiline (fumarate) manufactured by Arene Life Sciences Private Limited, supporting its availability as a…
Launches WHO’s prequalification procedure for medical devices, signposting a new pathway for manufacturers to seek WHO endorsement and broader market access.
Adds the DiaCarta Inc. QuantiVirus MPXV Test Kit to WHO’s Emergency Use Listing (EUL) for mpox diagnostics, enabling countries and procurers to source…
Announces the 2026 joint UNICEF/UNFPA/WHO meeting with manufacturers and suppliers (9–12 Nov 2026, hybrid, WHO Academy Lyon) focused on building resilient…
Launches WHO PQT eCTD submission capability via the ePQS Portal, enabling a harmonized electronic format to improve dossier lifecycle management and streamline…
Clarifies WHO prequalification expectations for plain-language descriptions of the visual appearance of oral dosage forms in WHOPARs, improving consistency and…
Adds three pediatric primaquine (as phosphate) tablet strengths by Ipca, India to the WHO Prequalification Unit (PQT) prequalified list for prevention of…
WHO prequalification has been granted for pyrazinamide manufactured by Resonance Specialities Limited under the WHO API prequalification procedure, enabling…
Invites manufacturers to submit Expressions of Interest for WHO Prequalification evaluation of specific childhood cancer medicines, including six paediatric…
Expands the WHO API prequalification Expression of Interest (EOI) process to include additional APIs—Hydrocortisone (sodium succinate), Dactinomycin…
Adds QCIL’s artemether/lumefantrine 20 mg/120 mg tablet (MA211) to the WHO Prequalification list, supporting availability of a quality-assessed ACT from…
Adds WHO PQT product TB415 (Isoniazid/moxifloxacin hydrochloride/rifapentine FDC tablet) from Lupin, India, to the prequalified list as the first FDC product…
WHO prequalifies Lamivudine API manufactured by Jiangxi Desano Pharmaceutical Co. Ltd., enabling manufacturers of finished pharmaceutical products (FPPs) for…